Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls
NCT ID: NCT02809222
Last Updated: 2021-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2016-10-25
2021-03-01
Brief Summary
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Studies showed that supplementation with AA can change the proliferation status of MDS cells. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients with myelodysplastic syndromes advanced in their treatment or recently diagnosed during a follow-up of 12 months.
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Detailed Description
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Ascorbic acid (AA) is an actor of the regulation of the oxidative metabolism in the human body. In vitro studies showed that supplementation with AA can change the proliferation status of MDS cells . Guinea pigs with a phenotype with excess of ROS supplemented with AA have less somatic mutations and less MDS. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML.
To our knowledge no study have demonstrated the variations of the parameters of the oxidative metabolism during the evolution of MDS. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients diagnosed with MDS in treatment or recently diagnosed during a follow-up of 12 months. During the follow-up a collection of plasma from volunteers and patients will be created for later analysis.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patients with MDS at diagnosis
The intervention, specific to the study, is to take blood samples on patients with MDS at diagnosis. A quality of life questionnaire will also be used to monitor patients
Samples
Blood samples
Quality of life questionnaire
Questionnaire to assess the quality of life of cancer patients
Patients with MDS in treatment
The intervention, specific to the study, is to take blood samples on patients with MDS receiving treatment. A quality of life questionnaire will also be used to monitor patients
Samples
Blood samples
Quality of life questionnaire
Questionnaire to assess the quality of life of cancer patients
Healthy volunteers
The intervention, specific to the study, is to take blood samples on patients healthy volunteers.
Samples
Blood samples
Interventions
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Samples
Blood samples
Quality of life questionnaire
Questionnaire to assess the quality of life of cancer patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient diagnosed for less than 4 months before inclusion
* Patient untreated by other means than blood transfusions
* Age ≥ 60 years
* Patient affiliated to social security scheme
* Informed consent signed by the patient
* Diagnosis of myelodysplastic syndrome according to the 2008 WHO classification
* Patient not included in patients MDS "at diagnosis" group
* Patient diagnosed for more than 12 months
* Treated with hypomethylating agents and/or erythropoiesis-stimulating agents and/or blood transfusions.
* Age ≥ 60 years
* Patient affiliated to social security scheme
* Informed consent signed by the patient
* Age ≥ 60 years
* Patient affiliated to social security scheme
* Informed consent signed by the patient
Exclusion Criteria
* Patient with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Active inflammatory disease
* Patient under legal protection measure
* Patient unwilling or who cannot submit to prospective biological follow-up
2. Patients MDS "in treatment" group selection criteria:
* Previous allogenic stem cell transplantation
* Patient with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Active inflammatory disease
* Patient under legal protection measure
* Patient unwilling or who cannot submit to prospective biological follow-up
3. Healthy volunteers group selection criteria:
* History of another primary malignancy that is currently clinically significant or currently requires active intervention
* History of active inflammatory diseases
* Volunteer under legal protection measure
* Volunteer unwilling or who cannot submit to prospective biological follow-up
60 Years
ALL
Yes
Sponsors
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Tours Autogreffe
UNKNOWN
Novartis
INDUSTRY
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Emmanuel GYAN, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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Clinical Research Center, University Hospital, Tours
Tours, , France
Department of Haematology and Cell Therapy, University Hospital, Tours
Tours, , France
Countries
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References
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Das A, Dey N, Ghosh A, Das T, Chatterjee IB. NAD(P)H: quinone oxidoreductase 1 deficiency conjoint with marginal vitamin C deficiency causes cigarette smoke induced myelodysplastic syndromes. PLoS One. 2011;6(5):e20590. doi: 10.1371/journal.pone.0020590. Epub 2011 May 31.
Ghoti H, Amer J, Winder A, Rachmilewitz E, Fibach E. Oxidative stress in red blood cells, platelets and polymorphonuclear leukocytes from patients with myelodysplastic syndrome. Eur J Haematol. 2007 Dec;79(6):463-7. doi: 10.1111/j.1600-0609.2007.00972.x. Epub 2007 Nov 1.
Hole PS, Darley RL, Tonks A. Do reactive oxygen species play a role in myeloid leukemias? Blood. 2011 Jun 2;117(22):5816-26. doi: 10.1182/blood-2011-01-326025. Epub 2011 Mar 11.
Chung YJ, Robert C, Gough SM, Rassool FV, Aplan PD. Oxidative stress leads to increased mutation frequency in a murine model of myelodysplastic syndrome. Leuk Res. 2014 Jan;38(1):95-102. doi: 10.1016/j.leukres.2013.07.008. Epub 2013 Aug 16.
Levine M, Rumsey SC, Daruwala R, Park JB, Wang Y. Criteria and recommendations for vitamin C intake. JAMA. 1999 Apr 21;281(15):1415-23. doi: 10.1001/jama.281.15.1415.
Park CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30.
Park CH, Kimler BF. Growth modulation of human leukemic, preleukemic, and myeloma progenitor cells by L-ascorbic acid. Am J Clin Nutr. 1991 Dec;54(6 Suppl):1241S-1246S. doi: 10.1093/ajcn/54.6.1241s.
Park CH, Kimler BF, Bodensteiner D, Lynch SR, Hassanein RS. In vitro growth modulation by L-ascorbic acid of colony-forming cells from bone marrow of patients with myelodysplastic syndromes. Cancer Res. 1992 Aug 15;52(16):4458-66.
Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.
Parker JE, Fishlock KL, Mijovic A, Czepulkowski B, Pagliuca A, Mufti GJ. 'Low-risk' myelodysplastic syndrome is associated with excessive apoptosis and an increased ratio of pro- versus anti-apoptotic bcl-2-related proteins. Br J Haematol. 1998 Dec;103(4):1075-82. doi: 10.1046/j.1365-2141.1998.01114.x.
Parker JE, Mufti GJ, Rasool F, Mijovic A, Devereux S, Pagliuca A. The role of apoptosis, proliferation, and the Bcl-2-related proteins in the myelodysplastic syndromes and acute myeloid leukemia secondary to MDS. Blood. 2000 Dec 1;96(12):3932-8.
Saito N, Miyamoto M, Gotoh U, Yoshitomi S. Effect of biscoclaurine alkaloids, prednisolone and ascorbic acid on myelodysplastic syndrome with pancytopenia: a case report. Eur J Haematol. 2000 Jan;64(1):61-5. doi: 10.1034/j.1600-0609.2000.9l036.x. No abstract available.
Welch JS, Klco JM, Gao F, Procknow E, Uy GL, Stockerl-Goldstein KE, Abboud CN, Westervelt P, DiPersio JF, Hassan A, Cashen AF, Vij R. Combination decitabine, arsenic trioxide, and ascorbic acid for the treatment of myelodysplastic syndrome and acute myeloid leukemia: a phase I study. Am J Hematol. 2011 Sep;86(9):796-800. doi: 10.1002/ajh.22092. Epub 2011 Aug 3. No abstract available.
Other Identifiers
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2016-A00539-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHAO16-EG/PLASMYC
Identifier Type: -
Identifier Source: org_study_id
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